Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults with Osteosarcoma
Research type
Research Study
Full title
Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults with Osteosarcoma
IRAS ID
162192
Contact name
Quentin Campbell Hewson
Contact email
Sponsor organisation
Eisai Ltd
Eudract number
2013-005534-38
Research summary
Summary of Research
Lenvatinib (E7080) is an investigational drug that is being developed for the treatment of cancer in adults and in children, including differentiated thyroid cancer (DTC) and osteosarcoma. This phase I/II study has 5 cohorts (groups) and children and adolescents from age 12 to <18 years will participate.
The purpose of 2 of the cohorts (Cohort 1 and cohort 3A) is to establish the recommended dose (RD) of Lenvatinib, taken on its own (cohort 1) or in combination with chemotherapy (cohort 3A).
The purpose of the other 3 cohorts (Cohort 2A, 2B and 3B) is to look at the efficacy and tolerability (i.e., does it have any side effects) of Lenvatinib at the recommended dose established in cohorts 1 and 3B. Lenvatinib will be assessed both on its own (cohort 2A and 2B), and in combination with chemotherapy (cohort 3B). Cohort 2A will be for participants with DTC and Cohort 2B will be for participants with osteosarcoma.Participants benefiting from study treatment (in the opinion of the investigator) may continue to receive treatment until disease progression, intolerable toxicity (side effects), initiation of another anti-cancer therapy, voluntary
discontinuation by the participant, or study termination by the sponsor, whichever
occurs first.Summary of Results
A copy of the Lay Summary of study results will be made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DtUrKMLtn-2FpDt977A2phDvl00GD0cKCDbT3Kng0Bj5J1l7CaRZIfi-2F4uq-2Ff7bY3c1ea7K_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLQjuR1aAVvEZW3em-2FgkNuhjo-2BHgDGl3cC4iedd82NsyjCpyX9YJ3A2sMIu8WF6sgJBdpMIa729uRYx0UR0lgZB4Xq4RVnyTBqdQBn6KUDqheTdldndtNxotLMrlLBgk3mzC9HKWViyExVx132IQHr3iLnk-2FE7TGLPVqrIuVlbJcw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cb9d16d7d91fa442cdc0d08dae1e7cb5d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638070682907955344%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3KGluNF4Rg0Q47PM6qhQ4GbFzp5KBgiyIt2QMOXSCuk%3D&reserved=0
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1119
Date of REC Opinion
21 Oct 2014
REC opinion
Further Information Favourable Opinion